Phase IIa study to evaluate the safety, blood concentration and effect on the body of repeated administrations of PRS-080#022-DP to patients with chronic kidney disease undergoing dialysis and suffering from decreased amount of red blood cells

Phase 1

• Conditions: Anemia of chronic disease; MedDRA version: 20.0 Level: LLT Classification code 10054310 Term: Anemia of chronic disease System Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-004472-21-DE
• Lead Sponsor: Pieris Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

1. Patients with stage 5 CKD having been on hemodialysis for at least 90 days;
2. Male and post-menopausal (no menses for at least 12 months without an alternative medical cause) female patients with an age of =18 years and with a maximum BW of 85 kg;
3. Patients being on stable erythropoiesis-stimulating agent (ESA) dose with the beginning of Screening;
4. Patients being on stable oral or intravenous iron doses with the beginning of Screening. Iron will be kept stable for a minimum of 2 weeks during the screening period before it will be discontinued one week before the first treatment;
5. Mean of 3 Hb values during the screening period, each obtained at least 7 days apart must be =10.5 g/dL, with a difference of =1.0 g/dL between the lowest and highest value;
6. Serum ferritin concentration =200 ng/mL;
7. TSAT =30%;
8. Plasma hepcidin concentration at least 5 nmol/L;
9. Male patients with a female partner of childbearing potential agree to use a medically acceptable method of contraception (e.g., condoms, sexual abstinence, vasectomy), not including the rhythm method for 30 days after administration of the study medication.
10. The patient is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions, and has duly signed the informed consent form (ICF). Patient agrees to comply with the protocol-mandated procedures and visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Anemia due to causes other than CKD, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy;
2. Blood transfusion within 2 months before administration of study medication;
3. Previous enrollment in this study;
4. Patients treated with PRS-080#022-DP in a former clinical study;
5. Current or previous (within 60 days or 5 half-lives before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study;
6. Employees of the sponsor or patients who are employees or relatives of the investigator;
7. Known allergy to any component of the PRS-080#022-DP formulation;
8. Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (anti-HCV Ab), or HIV; serology test results not older than 3 months are accepted;
9. Planned surgery during the study period;
10. Known or suspected active infection;
11. Active or chronic gastrointestinal bleeding, or known coagulation disorder;
12. Unwilling or unable to comply with the protocol, in the judgment of the investigator;
13. Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy (sudden circulatory disturbances of an organ or specific region of the body) or coronary artery bypass grafting <3 months prior to Screening;
14. Congestive heart failure: New York Heart Association Class III or IV;
15. Peripheral arterial disease with necrosis, stage IV (Fontaine) or grade III (category 5 and 6, Rutherford);
16. Screening serum folate and vitamin B12 clinically significant below lower limit of normal judged by the investigator;
17. History of malignancy
18. Any medical condition that in the judgment of the investigator might interfere with study participation or jeopardize patient’s safety during the study (e.g., active infection).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified